Efficacy and Safety Study of ABI-007 Plus Capecitabine as First-line Chemotherapy for Advanced Gastric Cancer Patients

Inclusion Criteria:

* signed informed consent form;
* histologically or cytologically confirmed gastric cancer;
* Age 18-75 years;
* Advanced or recurrent, metastatic disease;
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
* Life expectancy of at least 12 weeks;
* At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors );
* no prior history of chemotherapy or beyond 6 months after the end of systemic adjuvant treatment;
* Haematopoietic status:

  * Absolute neutrophil count \> 1.5 x 109/L;
  * Platelet count \> 90 x 109/L;
  * Hemoglobin at least 90g/l;
* Hepatic status:

  * Bilirubin ≤ 1.5 x upper limit of normal (ULN);
  * AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤ 5 times ULN (with liver metastasis);
  * ALP ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver or bone metastasis);
  * serum albumin ≥ 30g/L;
* Renal status:

  * Creatinine ≤ 1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥ 40 mL/min;
* Able to swallow and retain oral medication;

Exclusion Criteria:

* peripheral neuropathy of grade 2 or greater;
* symptomatic brain metastasis;
* known history of uncontrolled or symptomatic angina;
* clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;
* dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
* active or uncontrolled infection;
* pregnant or lactating women;
* dysmetabolism with nanoparticle Albumin-bound paclitaxel or Capecitabine
* unable to swallow and retain oral medication,intestinal Obstruction,alimentary tract hemorrhage